October 2019

Cover Story p. 01Actual Events p. 01Corporate News p. 02New Products p. 03Regulatory Affairs p. 04New TechnicalRecources p. 04 - 05New Information Material p. 06Fairs and Seminars p. 06

Family Latest News

INDUSTRY EVENTS

AAPS Pharma Sci 360 Annual Meeting03 – 06 November 2019rd th

San Antonio – Booth 747

Meet withJRS PHARMA:

Alginates p. 01Industry Events p. 01Corporate News p. 02Corporate News p. 03New Products p. 04Regulatory News p. 05New Technical Material p. 05Biopharmaceutical p. 06

JRS – our ew European Manufacturer ofY NAlginates

On ,31 October 2018 JRS Marine Products Landerneaust

became part of the JRS family. Located on the west coastof France, the state-of-the-art facility is totally dedicatedto the production and development of natural basedEuropean alginates for pharmaceutical and food appli-cations. The former GRINDSTED production line wasrebranded, and is now part of our new and innovativeVIVAPHARM® product range. Alginates are used inseveral different applications such as medical, food-

ust ff, technical, and textile.

In the pharmaceutical industry, seaweed is in highdemand as a natural based ingredient. Alginates, partof the hydrophilic polysaccharide family, are extractedfrom a variety of brown seaweeds. VIVAPHARM®

Sodium Alginate can be used as thickening agent, sus-andpending agent, disintegrating agent for controlled

release applications. isVIVAPHARM Alginic Acid® usedmainly as disintegrant and dispersing agent withemulsifying character. VIVAPHARM Calcium Alginate®

is designed for wound care applications due to itsfavorable properties, such as biocompatibility and non-toxicity.

Please contact your local JRS PHARMA representativeto find the right product for yourVIVAPHARM Alginate®

specific formulation.

CPhi worldwide 05 – 07 November 2019• th th

Frankfurt – Booth 102B40

CPhi India 26 – 28 November 2019• th th

Delhi – Booth 8.P20

PharmTech Moscow19 – 22 November 2019th nd

Moscow – Booth A1023

CORPORATE NEWS

JRS Family Latest News 10/19

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JRS India

Rettenmaier India Pvt Ltd continues to grow with theirnew office at Lodha Supremus, Mumbai. Under theleadership of Mr. Rohit Raut and Mr. Akshay Dalal,Rettenmaier India has successfully created dedicatedsale , customer service, , warehousing and technicals QAservice departments to serve the Pharma business. Inconjunction with the construction of a new MCC plant,which is about to start production, new pharmaceuticalappplication lab was built. In addition Rettenmaier Indiaestablished a cooperation with a third party CRO lab.

JRS Turkey

Founded in 2018, Rettenmaier Turkey Doğal Elyaf TicaretLimited Şirketi located in Istanbul, is now fully operational,

and ready to assist customers in the region. ManagingDirector Emin Ergan, chemist with long xperience-term ein pharma distribution business, and his assistanttheMrs. Emine Tekisik, took over responsibility the growingof

70 customers tookPharma business. In October 2019,advantage of the first JRS Pharma customer seminar inTurkey More to follow..

JRS Increases its International Footprint:

South Korea

Located in Seoul's local government district Seocho,Rettenmaier Korea Ltd. is now operational and servingcustomers with JRS PHARMA's high quality Excipients,together with our long distributor Whawon. The JRS-termteam is led by General Manager Mr. Jay Moon Mr. Mason.Jang the Life Science sector.is responsible for SouthKorea is -one of the most innovative and quality drivenpharmaceutical markets, Rettenmaier Korea Ltd. ishappy to offer highest quality products combined withtechnical and regulatory support.

JRS Introduces Flowability Tester

One of the most widely used methods to characterizepowder flow is to messure the “Angle of Repose”.This method is based on the measurement of the heightof a powder cone having a defined base diameter. Usingthese two measures, the slope of the cone can easily

.be calculated A shallow slope indicates good powderflowability, whereas the slope gets steeper with de-creasing flowability. For best results, this method re-quires very accurate and reproducible measurementof the cone height.

inJRS PHARMA's TCCHolzmühle have there-fore developed an appa-ratus, which allowscontactless, highprecision determinationof the height using a linelaser and a digital calliper.

JRS Family Latest News 10/19

CORPORATE NEWS

JRS PHARMA's 7 MCC anufacturing sites offer worldmclass excipients to our international customers.This global network allows for regional sourcing, provi-ding faster shipping at reduced costs. JRS PHARMAcontinues to improve its industry-leading supply chainto grow along the increasing demand worldwide.The two new State-of-the-Art manufacturing facilities inChangzhou, China and Gujarat, India are designated toserve primarily the fast growing industries in India,China and rest of Asia. Customers across the globehave already begun utilizing the Rettenmaier NaturalFiber Manufacturing (Changzhou) Co., Ltd. as theirregional MCC source. The manufacturing site obtainedalready Halal, Kosher, ISO 9001 and its Productionlicense from the Chinese FDA. The Product License isexpected early Q2 2020 which will allow JRS to sell theproducts within China in the future.

JRS Pharma Oy,Nastola, FinlandEMCOCEL®

®PROSOLV SMCC

Rettenmaier Natural Fiber,Manufacturing (Changzhou) Co.,Ltd., ChinaVIVAPUR®

JRS PHARMA LP,Cedar Rapids II,PlantUSAVIVAPUR®

FLOCEL®

Microcellulose WeissenbornGmbH & Co. KG, GermanyEMCOCEL®

®PROSOLV SMCCEASYtabPROSOLV®

VIVAPUR®

JRS PHARMA LP,Cedar Rapids Plant I,USAEMCOCEL®

®PROSOLV SMCC

JRS PHARMA &Gujarat Microwax

. Plant IPrivate Ltd ,Gujarat, IndiaFLOCEL®

JRS PHARMA &Gujarat Microwax

Plant IVPrivate Ltd. ,Gujarat, IndiaEMCOCEL®

FLOCEL Plus®

(starts Q4 2019)

NEW

NEW

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International Meeting of MCC lant anagers andJRS P MT Tthe echnical eam in Weißenborn.

JRS Pharma - The Leader in MCCTwo More Production Sites for Maximum Supply Security for the Fast Growing Economies in Asia

Opening of the New State-of-the-Art FacilityPlant IV Gujarat,Gujarat Microwax Private Ltd. , India

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JRS Family Latest News 10/19

NEW PRODUCTS

Introducing Magnesium StearateLUBRI-PREZ��

– from Sudeep

Earlier this year, JRS PHARMA announced that our JRSpartner Sudeep Pharma Pvt. Ltd. production ofstartetMagnesium Stearate. is available inLUBRI-PREZ��

USP/BP/EP/ armonized grades for a variety ofhapplications. Magnesium Stearate is the traditionaltablet lubricant designed for solid dosage forms. It is anice fit to the JRS Pharma product range.

Alginates Now Available from JRS

Line Extension: Calcium Phosphate /EMCOMPRESS TCP Now Available®

Tricalcium phosphate is preferably used as excipientin mineral fortification health supplements due to itshigh content of both calcium and phosphorous. JRSPHARMA's grades (DC andEMCOMPRESS TCP®

Powder) are compliant with the latest pharmaceuticalmonographs. Due to their very low heavy metal andaluminum content, they meet the E 341 (iii) regulation,FCC and California Prop 65, and therefore suitablearefor the use in nutraceutical applications.

VIVAPHARM® Alginic Acid

VIVAPHARM® Sodium Alginate

VIVAPHARM® Calcium Alginate

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+

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Name Solubility incold water

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Solubility in hotwater

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Gel formingwith Calcium

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Swells in cold water

VIVAPHARM® Pectins

On September 30th JRS Silvateam Ingredients Srl., ajoint venture between the Italian group Silvateam Spaand the German JRS Group was closed in order to join,forces in the production and sales of pectin and textu-rizing systems as well as distribution of tara gum.The joint venture will invest significantly in developmentand production of novel vegetable based texturizing-solutions with high consumer acceptance to respondto the increasing demand for label friendly food ingre-dients, e.g. for gummies.

One-Stop-Shop: JRS PHARMA Adds3 New Product Categories

Very Popular as Excipient in Health Supplements

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JRS Family Latest News 10/19

• Wallchart Product Overviewwith Pharma/Nutra

• VIVAPHARM Povidone® InformationLeaflet PVPP•

• Leaflet PVP/VA 64• Leaflet PVP K25, K30

• VIVAPHARM Alginates®

• Application of in the FormulationPROSOLV ODT G® 2of Ondansetron Orally – Disintegrating Tablets

• Matrix Effects on the Performance of (I) –DisintegrantsHydrophobic Tablets

• The Effect of Humidity on ContainingTablet SurfacesDifferent Types of Superdisintegrants

• The influence of matrix plasticity on lubricant effects

• VIVAPUR MCG X® as a Stabilizer for Nutraceutical Emulsions900 F

New Technical Papers

Updated Brochures

• PROSOLV SMCC® Silicified Microcrystalline Cellulose

• EMCOMPRESS® Dibasic Calcium Phosphate Dihydrate

• MCC Brochure Folder with Product Inlays

New Information

DMFs for your China Business

As one of the industry leaders in excipient solutions,JRS PHARMA strives for global regulatory compliance.In order to manufacture and sell pharmaceuticalproducts in China, all ingredients must have a ChineseDrug Master File (cDMF). The National MedicalProducts Administration (NMPA, former CFDA) is theChinese agency tasked to draft laws and regulations fordrugs and medical devices in China. These cDMF filingsallow global pharmaceutical companies to manufactureand sell pharmaceutical products in China, u ng manysiof JRS PHARMA's excipients.

cDMFs Filed:DMFs forWe strive to file all relevant Excipients for the

Chinese Market, above all, the MCC produced in ournew State-of-the-Art Chinese production siteChangzhou.

Microcrystalline Cellulose

Sodium Starch Glycolate

Croscarmellose Sodium

Sodium Stearyl Fumarate

Hydrogenarted Vegetable Oil

Powdered Cellulose

Crospovidone

VIVAPUR®

(105/101/102//102SCG/12/200 112)

VIVASTAR® P

VIVASOL®

PRUV®

LUBRITAB®

ELCEMA® 150F

VIVAPHARM®

Crospovidone

✓

✓

✓

✓

✓

✓

✓

Product Type /Grade cDMFavailable

NEW TECHNICAL MATERIAL

REGULATORY NEWS

More coming soon...

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JRS Family Latest News 10/19

CONTACT US

FAIRS & SEMINARS

FAIRS

03 – 06 November 2019rd th

AAPS Pharma Sci 360 AnnualMeetingSan Antonio – Booth 747

05 – 07 November 2019th th

CPhi worldwideFrankfurt – Booth 102B40

19 – 22 November 2019th nd

PharmTech MoscowMoscow Booth A1023–

26 – 28 November 2019th th

CPhi IndiaDelhi – Booth 8.P20

SEMINARS

Technical Seminars

19 – 21 November 2019th st

Capsule Academy 2019, Germany

10 June 2020th

UK Technical Seminar in UK

BIOPHARMACEUTICAL

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JRS PHARMA GMBH & CO. KG73494 Rosenberg (Germany)Phone: +49 7967 152-312ExcipientsService@JRSPharma.de

www.jrspharma.com

JRS PHARMA FAMILYA Member of the JRS GroupThe Global Excipient Maker

Celonic ntroduces ew State-of-the-ArtI NFacility in Heidelberg

The Celonic Group is gearing up to expand its Heidelbergsite with an approximately 2 000 square meter build-,ing. This new location adds more than 100 work spa-ces including offices and labs.

This will double the number of employees at Celonic'slargest GMP-manufacturing site and w be used forilladministrative and management department, and forLabs for Quality Control department.

The fully equipped offices and labs will be ready bysummer 2020.

The new GMP facility construction “Hall N” includesan expansion of the production capacity at Celonic'sHeidelberg site. Total area of “Hall N” is estimated tohave approx. 4,500 square meters with a clean roomarea of approx. 2,000 square meters.

The planning for “Hall N” started in summer 2018 andit will be fully functional for GMP production in thesecond quarter of 2020.

The planned clean room area will produce mainlybiopharmaceuticals for Phase III clinical trials or withregulatory approval. Additionally, the design of theclean rooms will comply with the standards of the USFood and Drug Administration (FDA) and the EuropeanMedicines Agency (EMA).

Administration Building„Hall N“